阿达木单抗治疗类风湿关节炎的疗效和安全性

目的:评价肿瘤坏死因子α拮抗剂阿达木单抗短期治疗类风湿关节炎(RA)的临床疗效及安全性,同时检测治疗前后类风湿因子(RF)和抗环瓜氨酸肽抗体(抗CCP抗体)滴度的变化,为RA疗效评估寻找新的指标。方法:随机双盲平行试验,纳入40例活动性RA患者,按2∶2∶1的比例被随机分配到试验组或对照组,试验组分为80 mg阿达木单抗+甲氨喋呤(MTX)、40 mg阿达木单抗+MTX两组,对照组为安慰剂+MTX。受试者隔周接受皮下注射阿达木单抗或同等体积的安慰剂,并在试验第0,2,4,8,12周随访,评价疗效及不良事件收集。疗效采用ACR核心标准评定。次要疗效指标包括压痛和肿胀关节数、晨僵时间、疼痛视觉模拟评分(VAS评分)、健康评估问卷(HAQ)和CRP。基线时及12周治疗结束后检测RF、抗CCP抗体。结果:试验组32例,对照组8例。12周后试验组患者ACR20、ACR50和ACR70缓解的比例都显著高于对照组(P<0.01);试验组患者关节触痛数、关节肿胀数、晨僵持续时间、疼痛VAS评分及健康状况问卷(HAQ)、CRP等次要疗效指标均较基线时水平明显降低(P<0.05);试验组RF血清滴度和抗CCP抗体均较基线时水平显...     

托珠单抗治疗活动性全身型幼年特发性关节炎的临床观察

目的研究托珠单抗治疗活动性全身型幼年特发性关节炎(JIA)的近期临床疗效和不良反应。方法 26例活动性全身型JIA患儿接受托珠单抗(0周,第2,4,6,8周),同时继续口服稳定剂量的改善病情的抗风湿药(DMARDs),以美国风湿病学会(ACR)儿科30、50作为病情改善评估标准。评估项目包括:关节肿胀、疼痛、活动受限数目、部位、程度,机体功能的评估,实验室炎性指标如C反应蛋白(CRP)、红细胞沉降率(ESR)等变化。结果 26例JIA患儿托珠单抗治疗2周时ACR儿科30、50分别为47%(7/15例)、20%(3/15例),8周时分别为80%(12/15例)、53%(8/15例);托珠单抗治疗2周后,CRP、ESR等炎性指标不同程度下降,治疗4周后比较差异有统计学意义(P<0.05)。治疗前后血清中白细胞介素(IL)-6水平比较差异无统计学意义(P>0.05)。结论托珠单抗治疗活动性全身型JIA近期效果明显,安全性、耐受性较好。     

利妥昔单抗治疗类风湿关节炎的临床研究进展

利妥昔单抗是一种特异性针对CD20分子的基因工程抗体,能与B淋巴细胞表面的CD20结合,并通过补体介导的细胞毒作用等机制对B淋巴细胞进行特异性清除,从而达到治疗作用.利妥昔单抗最初作为抗淋巴瘤药物首先获得美国FDA认证,近年来被应用于类风湿关节炎等自身免疫病的治疗,取得了较好的疗效.现对其治疗类风湿关节炎的作用机制、临床应用和研究进展做一综述.     

利妥昔单抗超适应证治疗膜性肾病的评价研究

目的：评估利妥昔单抗超适应证治疗膜性肾病的合理性和有效性,为利妥昔单抗的实际临床应用提供参考。方法：依托“医疗机构ADE主动监测及智能评估警示系统（ADE-ASAS）”,收集我院2005年1月1日–2020年12月31日应用利妥昔单抗治疗膜性肾病的患者,进一步评估利妥昔单抗的近期、远期疗效以及药物安全性,并探索可能的疗效预测指标。结果：利妥昔单抗治疗膜性肾病的总有效率为49.65%,复发率为6.38%。其中治疗3、6、12个月后的有效率分别为32.56%、39.29%、54.09%,差异具有统计学意义（P<0.05）。利妥昔单抗治疗3、6、12个月后抗PLA2R抗体滴度均较治疗前降低（P <0.01）,且治疗有效组较治疗无效组抗PLA2R抗体滴度均有所下降（P<0.01）。在安全性方面,利妥昔单抗治疗后不良反应发生率为17.98%,主要表现为感染及全身性损害;严重不良反应发生率为11.84%,主要表现为感染及过敏性休克。结论：利妥昔单抗治疗膜性肾病具有一定疗效,且远期疗效优于近期疗效,但需关注利妥昔单抗致感染及过敏性休克等严重不良反应;此外,本研究结果提示抗PLA2R...     

英夫利西单抗治疗进展性类风湿关节炎的疗效与安全性分析

目的评价英夫利西单抗治疗进展性类风湿关节炎(RA)的疗效和安全性。方法选择80例进展性类风湿关节炎及疾病活动性指数(DAS28)≥3.2患者,随机分两组,对照组40例给予甲氨蝶呤联合来氟米特,治疗组40例给予来氟米特、甲氨蝶呤联合英夫利西单抗治疗。分别在治疗0、6周及22周记录临床、实验室指标数值及关节肿胀及压痛数改善达20%(ACR20)、50%(ACR50)和70%(ACR70)的例数。结果对照组在6周时除关节肿胀数外,其他指标均无显著改善,22周时各项指标均有显著改善。治疗组在6周时各项指标均有改善,22周疗效更为显著具有统计学意义(P<0.05);ACR20在6周、22周ACR50、ACR70疗效均显著好于对照组。两组患者的不良反应发生率低且不严重。结论英夫利西单抗治疗进展性类风湿关节炎具有起效快、疗效显著,安全性较好的特点,值得临床推广与应用。     

新药研究与开发

FDA批准妥西珠单抗治疗中重度活动性类风湿性关节炎罗氏公司宣布美国FDA批准妥西珠单抗（tocilizumab）用于对一种以上肿瘤坏死因子拮抗剂治疗反应不佳的成人中重度活动性类风湿性关节炎。这是首个批准用于类风湿性关节炎治疗的抑制白细胞介素6的单克隆抗体,可以单药或与甲氨蝶呤及其他抗类风湿药联用。     

以B细胞为靶标的类风湿性关节炎的治疗

类风湿性关节炎(RA)是人类的一种系统性自身免疫性疾病。利妥昔单抗(rituximab)作为一种针对B细胞特异性抗原CD20的人-鼠嵌合单克隆抗体,是首个以B细胞为靶标治疗RA的药物。根据美国类风湿学学会(ACR)20,50,70反应标准,甲氨蝶呤与利妥昔单抗联用能显著减轻类风湿因子血清阳性的RA的体征和症状,且比较安全。在一项双盲对照的Ⅱ期临床试验中,贝利单抗(belimumab)有较好的耐受性和良好的效应。     

利妥昔单抗或对系统性类风湿血管炎有效

法国研究者在2011年11月10日在线发表于《Arthritis Care&Research》的报告中称,患类风湿关节炎相关性系统性血管炎的患者对利妥昔单抗治疗反应良好。有3/4的系统性类风湿血管炎(SRV)患者在每日接受利妥昔单抗治疗后病情得到完     

阿达木单抗治疗难治性类风湿关节炎的疗效及对骨代谢的影响

目的 探究生物制剂阿达木单抗治疗难治性类风湿关节炎(RRA)患者的疗效及对其骨代谢的影响。方法 42例RRA患者,均给予阿达木单抗治疗,对比治疗前和治疗1、3、6个月后的相关指标,观察治疗前后相关药物使用情况,观察治疗过程中药物不良事件发生情况。结果 治疗1、3、6个月后,患者C反应蛋白(CRP)、肿胀关节数(SJC)、压痛关节数(TJC)、类风湿关节炎病情活动度评价表(DAS28)评分与治疗前相比,差异有统计学意义(P<0.05)。治疗3、6个月后,患者血沉(ESR)、骨钙素和总Ⅰ型胶原氨基段延长肽(PⅠNP)与治疗前相比,差异有统计学意义(P<0.05)。阿达木单抗治疗前, 10例患者使用激素治疗,治疗3个月后仅4例使用激素治疗,且使用激素量明显减少,至治疗6个月后仅1例还使用小剂量激素。治疗1、3、6个月后患者联用抗风湿药物(DMARDs)种类下降,治疗6个月后, 10例未使用DMRADs, 31例使用1种DMRADs, 1例使用2种DMRADs。6个月阿达木单抗治疗期间, 42例患者中1例患者在首次注射后第3天出现注射侧手臂散在皮疹,伴轻度瘙痒,疑似过敏性皮疹,未予...     

难治性类风湿关节炎托珠单抗治疗临床观察

目的：研究注射托珠单抗注射液（雅美罗）治疗活动性RA 4周、8周、16周的临床疗效及不良反应。方法15例活动性RA患者接受托珠单抗注射液治疗,观察治疗前、第4、8、16周各项观察指标变化,并记录不良反应发生情况。观察指标有血常规、肝功能、肾功能、压痛关节数、肿胀关节数、ESR、CRP、DAS28评分。结果15例RA患者,托珠单抗注射液治疗后ESR、CRP均有不同程度改善,与治疗前比较差异有统计学意义（ P ＜0．01）;DAS28评分对治疗前、治疗后第4、8、16周进行比较,发现治疗后第4周即有显著改善,差异具有统计学意义（ P ＜0．01）。结论托珠单抗注射液能在短时间内迅速改善活动性RA的临床症状和实验室炎性活动指标,可显著改善病情。     

甲氨蝶呤联合环磷酰胺治疗类风湿关节炎的临床研究

目的 评价甲氯燥呤(MTX)联合环磷酰胺(CTX)治疗类风湿关节炎(RA)的疗效和安全性.方法 将152例RA患者随机分为单用MTX组56例、单用CTX组40例及MTX联合CTX组56例,疗程24周,在0、6、12、24周进行疗效及安全性评估,以美国风湿病学会(ACR)疗效评价指标和欧洲抗风湿病联盟(EULAR)疗效指标等进行疗效评价.结果 在24周,联合组达ACR20改善的患者为42例(81%),高于MTX组30例(56%)(30/54)及CTX组12例(35%)(12/54),差异有统计学意义(P<0.05);联合组达ACR50改善的患者为22例(41%),高于CTX组4例12%(4/34),(P<0.05),与MTX组22例(41%)(22/54)之间差异无统计学意义(P>0.05).结论 MTX联合CTX治疗能显著改善RA的症状、体征和实验室炎性指标,疗效优于单用.     

Comparative effectiveness of cycling of tumor necrosis factor-α (TNF-α) inhibitors versus switching to non-TNF biologics in rheumatoid arthritis patients with inadequate response to TNF-α inhibitor using a Bayesian approach

Alternative tumor necrosis factor-α (TNF-α) inhibitors and non-TNF biologics are available as treatment options for rheumatoid arthritis patients who exhibit inadequate response to TNF-α inhibitor (TNF-IR patients). These agents have considerable efficacy compared with placebo, but head-to-head comparisons among these agents have not been performed. The objective of this study was to use Bayesian approach to compare the effectiveness of cycling TNF-α inhibitors versus switching to non-TNF biologics in TNF-IR patients. A systematic review was conducted using MEDLINE and Cochrane library. Key endpoints were the American College of Rheumatology (ACR) responses of 20/50/70 and the health assessment questionnaire (HAQ) score change at six months. Bayesian outcomes were calculated as the probability that OR is greater than one and HAQ score change difference is less than zero. Compared with TNF-α inhibitors, non-TNF biologics were associated with higher ACR response rates; in ACR20, the OR was 1.639 for abatacept [P(OR > 1) = 90.7 %], 1.871 for rituximab [P(OR > 1) = 96.2 %] and 3.52 for tocilizumab [P(OR > 1) = 99.9 %]. Similar trends were shown in the HAQ change comparison; the median differences (MD) were ?0.259 for abatacept [P(MD < 0) = 100 %], ?0.160 for rituximab [P(MD < 0) = 98.2 %], and ?0.200 for tocilizumab [P(MD < 0) = 99.3 %]. In conclusion, switching to non-TNF biologics was more effective than cycling TNF-α inhibitor in TNF-IR patients.     

重组人Ⅱ型肿瘤坏死因子受体-Fc融合蛋白联合甲氨蝶呤治疗中重度类风湿关节炎的疗效与安全性

目的：观察国产重组人Ⅱ型肿瘤坏死因子受体-Fc融合蛋白（TNFRⅡ-Fc）与甲氨蝶呤（MTX）联合治疗中重度类风湿关节炎的疗效与安全性。方法：46例病人随机分为MTX组和TNFRⅡ-Fc联合MTX组,疗程24周。疗效评价采用美国风湿病学会（ACR）疗效评定标准。结果：治疗2周后,联合治疗组的ACR20改善率和ACR50改善率均显著高于MTX组（P〈0.05,P〈0.01）。治疗24周后,联合治疗组的ACR50改善率约为MTX组的2倍;ACR70改善率约为MTX组的3.5倍。与基线值相比,MTX组在治疗12周后DAS28明显下降,而联合治疗组在治疗2周后DAS28即有所下降。在治疗2～24周期间,联合治疗组的DAS28较基线值下降的幅度均显著大于MTX组。MTX组和联合用药组不良事件总的发生率分别为17.4%和30.4%,差异无显著意义。其中最常见的不良事件为恶心和上腹不适。结论：TNFRⅡ-Fc联合MTX较单用MTX能更有效控制类风湿关节炎的病情活动,且不良反应无明显增加。     

英利西单抗治疗活动性类风湿关节炎临床观察

目的 观察英利西单抗治疗活动性类风湿关节炎(RA)的临床疗效和安全性.方法 30例活动性RA患者分为研究组和对照组,各15例.研究组在每周口服甲氨蝶呤(MTX)10～15 mg基础上联合应用英利西单抗,在第0、2、6周接受3 mg/kg的英利西单抗静脉滴注;对照组口服相同剂量的MTX,联合应用其他改善病情抗风湿药(DMARDs),如柳氮磺吡啶、来氟米特或羟氯喹.疗程均为12周.结果 治疗6周后,研究组和对照组的临床症状和实验室指标均有改善,美国风湿病学会(ACR)20有效率分别为40%(6/15)和20%(3/15),差异有统计学意义(P＜0.05);ACR50有效率分别为27%(4/15)和6%(1/15),差异有统计学意义(P＜0.05).治疗12周后各项指标进一步改善.研究组和对照组的ACR20有效率分别为60%(9/15)和33%(5/15),差异有统计学意义(P＜0.05);ACR50有效率分别为40%(6/15)和13%(2/15),差异有统计学意义(P＜0.05).治疗6周后,研究组和对照组的临床症状和实验室指标均有改善.结果 表明,研究组在治疗12周后休息痛、关节肿胀和关节压痛改善明显,红细胞沉降率、C反应蛋白和类风湿因子改善情况也明显优于对照组.研究组和对照组治疗前简明疾病活动评分分别为(5.8±2.5)和(5.9±2.2)分,差异无统计学意义(P＞0.05).治疗6周后2组分别为(2.4±1.6)和(4.7±1.9)分,差异有统计学意义(P＜0.05).治疗12周后2组分别为(1.8±1.1)和(4.2±1.8)分,差异有统计学意义(P＜0.05).研究组共有2例患者出现不良反应,1例注射局部出现皮疹或红斑,未见局部溃疡和坏死.上述不良反应均自行消失,未中断治疗.1例患者出现上呼吸道感染,对症处理后症状消失,亦未中断治疗.结论 英利西单抗是安全有效的治疗RA的药物,可以更早期达到诱导缓解病情的目的.     

Clinical endpoint sensitivity in rheumatoid arthritis: modeling and simulation

The commonly used efficacy endpoints in Rheumatoid Arthritis (RA) clinical trials are American College of Rheumatology 20 % improvement criteria (ACR20), ACR50, and ACR70 response rates, and the 28-joint disease activity score (DAS28). Longitudinal models to quantitate the exposure–response relationships for ACRs and DAS28 score were developed for four biologics used for the management of RA. The models were then used to simulate the clinical outcome at various time points following different treatment regimens. Discriminative sensitivity of these endpoints was assessed using a power analysis. The trial simulation and subsequent power analysis showed that both ACR20 and DAS28 exhibit much lower power in distinguishing between two doses investigated compared with distinguishing treatment effect over placebo/Methotrexate (MTX) control. ACR20 response rate is generally more powerful in detecting treatment effect over placebo/MTX control as compared to DAS28. The findings of current study provide useful information which will help future clinical trial design for the treatment of patients with RA.     

Review of eight pharmacoeconomic studies of the value of biologic DMARDs (adalimumab, etanercept, and infliximab) in the management of rheumatoid arthritis

BACKGROUND: Treatment options for the management of rheumatoid arthritis (RA) have expanded from the traditional disease-modifying antirheumatic drugs (DMARDs) to include the biologic DMARDs that inhibit tumor necrosis factoralpha (TNF-a). OBJECTIVE: To assess the medical literature for studies of the economic value of biologic DMARDs, specifically the 3 TNF-a inhibitors (adalimumab, etanercept, and infliximab) used for the management of RA, compared with the traditional DMARDs such as sulfasalazine, antimalarials, penicillamine, gold, methotrexate, azathioprine, leflunomide, and cyclophosphamide. METHODS: A comprehensive search of the MEDLINE and HealthSTAR databases was conducted to identify cost-efficacy, cost-effectiveness, or cost-utility studies published in the English language (from 1966 through November 2004). The search terms and/or MeSH (medical subject headings) titles were cost-benefit analysis, rheumatoid arthritis, antirheumatic agents, antineoplastic and immunosuppressive agents. Studies were critically reviewed and quality was assessed using the Quality of Health Economic Studies instrument. Most studies evaluated the use of biologics among RA patients resistant to DMARDs. Studies were assessed with regard to comparators evaluated, measures of efficacy, perspectives, model duration, treatment duration, and discount rate. RESULTS: From 180 titles identified, 155 were excluded for the following reasons: 89 because they did not consider the drugs of interest, 15 because the population was not RA, 19 because of having the wrong drugs and population, 22 because they were review articles, and 10 because they were general articles. Twentyfive abstracts were accepted for further review. Of these, 13 abstracts were subsequently selected for full-text review. One of the authors identified a study not indexed in MEDLINE. Ultimately, 2 cost-effectiveness and 6 cost-utility studies were selected for this critical review. One study over 6 months reported that triple therapy with DMARDs (methotrexate-hydroxychloroquine-sulfasalazine) was cost effective for methotrexate-resistant patients, which is consistent with American College of Rheumatology (ACR) guidelines that support the use of triple therapy prior to biologics. The incremental cost-effectiveness ratio (ICER) was $1,500 per patient to achieve an ACR20 response for this triple therapy compared with no second-line agent. Overall, biologic therapies cost considerably more than traditional DMARDs but produced more quality-adjusted life-years (QALYs). Despite differences in design and assumptions, published economic models consistently reported ICERs <50,000 dollars per QALY gained for biologics compared with traditional DMARDs, although ICERs of >100,000 dollars were reported from sensitivity analyses. CONCLUSIONS: Clinical guidelines currently recommend the use of biologics as step therapy after failure of traditional DMARDs. Reported ICERs comparing biologics with traditional DMARDs are within a range that is comparable with other accepted medical interventions. The worth of the additional expenditure will ultimately be judged by formulary and policy decision makers because no maximum cost has been defined. Models can be used to inform decision makers, but they must be interpreted and applied carefully. More research is also needed to differentiate the relative economic value of the various biologic agents by therapeutic indication.     

Clinical response to golimumab in rheumatoid arthritis patients who were receiving etanercept or adalimumab: results of a multicenter active treatment study

Objective: Evaluate the efficacy and safety of subcutaneous (SC) golimumab?+?methotrexate (MTX) in patients with active rheumatoid arthritis (RA) despite etanercept?+?MTX or adalimumab?+?MTX therapy and evaluate whether intravenous (IV) golimumab could rescue patients who were nonresponders to SC golimumab.

Methods: In this multicenter, assessor-blinded, active-switch study of patients with RA (n?=?433) with inadequate response to etanercept or adalimumab?+?MTX, patients continued MTX and received open-label SC golimumab 50?mg every 4 weeks through week 12. DAS28-ESR good responders at week 16 continued open-label SC golimumab through week 52 (Group 1); nonresponders were randomized to double-blind golimumab SC 50?mg (Group 2-SC) or IV 2?mg/kg (Group 2-IV). Week 14 ACR20 was the primary endpoint; assessments continued through week 52 and for patients in the voluntary long-term extension through week 76. A major secondary endpoint was the proportions of patients with ACR20 response at week 52 relative to week 16 in Group 2-SC and Group 2-IV.

Results: At week 14, 34.9% (p?n?=?75) achieved an ACR20 (62.7%). In Groups 2-SC (n?=?91) and 2-IV (n?=?184), 13.2% and 9.2% had an ACR20 at week 52 relative to week 16, with no significant difference between the randomized groups; 42.9% and 47.8% achieved DAS28-ESR response relative to week 0. Through week 16, 4.6% of patients had a serious adverse event. No differences in the rates or types of adverse events were observed between SC and IV golimumab from weeks 16 to 52. The trial limitations included a higher than expected discontinuation rate as a result of a programming error.

Conclusion: SC golimumab?+?MTX significantly suppressed disease activity in RA patients with inadequate response to etanercept and/or adalimumab + MTX. Patients randomized to Groups 2-SC and 2-IV had lower response rates than Group 1, with no difference between SC or IV mode of administration. The safety profile with IV golimumab was comparable to that established with SC golimumab.

Trial registration: NCT01004432, EudraCT 2009-010582-23.     

雷公藤联合小剂量强的松治疗老年类风湿关节炎的疗效观察

目的观察雷公藤联合小剂量强的松治疗老年类风湿关节炎（RA）的临床疗效和安全性。方法 52例老年RA患者随机分为治疗组和对照组;治疗组（26例）口服雷公藤和小剂量强的松治疗,对照组（26例）口服雷公藤治疗,比较治疗前后两组患者临床症状和实验室指标的变化。结果治疗3个月后治疗组患者在晨僵时间、关节压痛数、关节肿胀数、患者VAS评分、红细胞沉降率（ESR）、C反应蛋白（CRP）、类风湿因子（RF）、DAS28指标上改善优于对照组（P〈0.05）,且两组治疗3个月后各项指标与治疗前比较,差异有统计学意义（P〈0.05）;治疗组患者ACR20、ACR50、ACR70缓解率优于对照组（P〈0.05）;两组不良反应发生率比较差异无统计学意义（P〉0.05）。结论雷公藤联合小剂量强的松治疗老年类风湿关节炎能快速改善临床症状和实验室指标,不良反应少。     

周期联合甲氨蝶呤环磷酰胺治疗类风湿关节炎的临床疗效及疗效预测因素分析

目的探讨周期联合甲氨蝶呤、环磷酰胺治疗类风湿关节炎(RA)的临床疗效和达到临床疗效的预测因素。方法本研究共纳入60例活动期RA患者,给予甲氨蝶呤(10～15mg/周)、环磷酰胺(400mg/2～3周)周期联合治疗。在第24周时对临床疗效进行评估。以治疗24周时达到美国风湿病学会(ACR)20为疗效标准,对基线时的14项参数[年龄、性别、病程、疼痛视觉模拟量表(VAS)评分、患者对疾病总体状况的评估(PGA)、医生对疾病总体状况的评估(PhGA)、压痛关节数、肿胀关节数、健康评估问卷(HAQ)、红细胞沉降率(ESR)、C反应蛋白(CRP)、激素的使用情况、类风湿因子(RF)和抗环瓜氨酸肽(CCP)抗体水平]进行Logistic单因素和多因素疗效预测分析。结果共58例RA患者完成24周疗效观察。在第24周时,79%(46/58)的患者达ACR20改善,55%(32/58)的患者达ACR50改善,21%(12/58)的患者达ACR70改善。24周时达到EULAR临床有效的患者比例为76%(44/58)。Logistic单因素和多因素分析显示:年龄、肿胀关节数是ACR20疗效的预测因素。结论甲氨蝶呤联合环磷酰胺治疗RA疗效显著,两者联合治疗能明显改善RA的症状、体征和实验室炎性指标;年龄和肿胀关节数是ACR20疗效的预测因素。     

重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗活动性类风湿性关节炎效果观察

目的研究重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（rhTNFR：Fc）对活动性类风湿关节炎（RA）的疗效。方法40例活动性RA随机分为两组,观察组皮下注射rhTNFR：Fc25mg,2次/周;对照组口服来氟米特（LEFT）20mg,1/d及甲氨蝶呤（MTX）15mg,1次/周。疗程为24周。治疗2、4、8、12、24周后,统计两组达到美国风湿病学会（ACR）20、ACR50、ACR70改善标准的情况。结果治疗2、4周后,观察组ACR20的比例明显高于对照组,差异有统计学意义（P〈0.05）;治疗8周后,观察组ACR20、50的比例均明显高于对照组,差异有统计学意义（P〈0.05）;治疗24周后,观察组ACR20、50、70的比例均显著高于对照组,差异有统计学意义（P〈0.05）。对照组中的消化道症状发生率明显高于观察组（P〈0.05）。结论 rhTNFR：Fc对活动性RA具有良好的疗效及安全性。